US-MA, Epidemiology Leader SR0041987-MZ
The Director, Epidemiology is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology research for product support at a global level, from early development through life cycle management. The Director, Epidemiology provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact cross-functional project opportunities and risks, to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs. The incumbent must be highly innovative, proactive and collaborative with mature team-working behaviors. As a member of the Outcomes Research and Epidemiology (ORE) department, an epidemiologist at Shire must have a broad view of the role of epidemiology and Pharmacoepidemiology in product support, contributing across target identification, through drug development, value demonstrations, market access, and post-approval effectiveness and safety. Epidemiologists interact with a wide range of internal and external customers to ensure appropriate communication of epidemiological issues and study results to stakeholders, including providing epidemiological support for interactions with regulatory authorities.
Describe the essential daily job functions and include % of time spent on each.
% of Time
Job Function and Description
Develop product epidemiology strategy for drug development, pharmacovigilance, and commercial purposes across the product life cycle
Propose, design, initiate, conduct, manage, report, and present epidemiologic studies, following through on all review stakeholder management, and compliance processes
Critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas
Contribute appraisal and synthesis of relevant epidemiological literature, including the support exploration of new disease areas
Pharmacovigilance support, including risk management; PASS development and delivery; contributions to RMPs, PSURs, and regulatory responses; understanding inherent risks associated with a given product s indication; providing population-level context for safety; understanding and responding to potential safety issues
Maintain awareness of regulatory requirements, payer trends, external pharmacoepidemiologic initiatives, and advances in pharmacoepidemiologic methodology; support strategic development of the Epidemiology function within Shire; remain current on the capabilities of key external research partners.
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and
necessary licenses or certificates. Specify which are required and which are preferred. For UK,
please do not use years of experience due to UK Legislation
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be
representative of the knowledge, skills, and abilities required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent s authority to make as well as those decisions that must be referred to a higher level.
Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the
job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.
Domestic and international travel required. Must have a global mindset. Fluency in main European languages would be desirable.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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